In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.
Physicians recognize the importance of patients' emotions in healing yet believe their own emotional responses represent lapses in objectivity. Patients complain that physicians are too detached. Halpern argues that by empathizing with patients, rather than detaching, physicians can best help them. Yet there is no consistent view of what, precisely, clinical empathy involves. This book challenges the traditional assumption that empathy is either purely intellectual or an expression of sympathy. Sympathy, according to many physicians, involves over-identifying with patients, threatening objectivity and respect for patient autonomy. How can doctors use empathy in diagnosing and treating patients rithout jeopardizing objectivity or projecting their values onto patients? Jodi Halpern, a psychiatrist, medical ethicist and philosopher, develops a groundbreaking account of emotional reasoning as the core of clinical empathy. She argues that empathy cannot be based on detached reasoning because it involves emotional skills, including associating with another person's images and spontaneously following another's mood shifts. Yet she argues that these emotional links need not lead to over-identifying with patients or other lapses in rationality but rather can inform medical judgement in ways that detached reasoning cannot. For reflective physicians and discerning patients, this book provides a road map for cultivating empathy in medical practice. For a more general audience, it addresses a basic human question: how can one person's emotions lead to an understanding of how another person is feeling?
In this hard-hitting indictment of the pharmaceutical industry, Ray Moynihan and Allan Cassels show how drug companies are systematically using their dominating influence in the world of medical science, drug companies are working to widen the very boundaries that define illness. Mild problems are redefined as serious illness, and common complaints are labeled as medical conditions requiring drug treatments. Runny noses are now allergic rhinitis, PMS has become a psychiatric disorder, and hyperactive children have ADD. Selling Sickness reveals how expanding the boundaries of illness and lowering the threshold for treatments is creating millions of new patients and billions in new profits, in turn threatening to bankrupt national healthcare systems all over the world. This Canadian edition includes an introduction placing the issue in a Canadian context and describing why Canadians should be concerned about the problem.
Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
This book demonstrates how to use multilevel and longitudinal modeling techniques available in the IBM SPSS mixed-effects program (MIXED). Annotated screen shots provide readers with a step-by-step understanding of each technique and navigating the program. Readers learn how to set up, run, and interpret a variety of models. Diagnostic tools, data management issues, and related graphics are introduced throughout. Annotated syntax is also available for those who prefer this approach. Extended examples illustrate the logic of model development to show readers the rationale of the research questions and the steps around which the analyses are structured. The data used in the text and syntax examples are available at www.routledge.com/9780415817110. Highlights of the new edition include: Updated throughout to reflect IBM SPSS Version 21. Further coverage of growth trajectories, coding time-related variables, covariance structures, individual change and longitudinal experimental designs (Ch.5). Extended discussion of other types of research designs for examining change (e.g., regression discontinuity, quasi-experimental) over time (Ch.6). New examples specifying multiple latent constructs and parallel growth processes (Ch. 7). Discussion of alternatives for dealing with missing data and the use of sample weights within multilevel data structures (Ch.1). The book opens with the conceptual and methodological issues associated with multilevel and longitudinal modeling, followed by a discussion of SPSS data management techniques which facilitate working with multilevel, longitudinal, and cross-classified data sets. Chapters 3 and 4 introduce the basics of multilevel modeling: developing a multilevel model, interpreting output, and trouble-shooting common programming and modeling problems. Models for investigating individual and organizational change are presented in chapters 5 and 6, followed by models with multivariate outcomes in chapter 7. Chapter 8 provides an illustration of multilevel models with cross-classified data structures. The book concludes with ways to expand on the various multilevel and longitudinal modeling techniques and issues when conducting multilevel analyses. It's ideal for courses on multilevel and longitudinal modeling, multivariate statistics, and research design taught in education, psychology, business, and sociology.
During her two decades at The New England Journal of Medicine, Dr. Marcia Angell had a front-row seat on the appalling spectacle of the pharmaceutical industry. She watched drug companies stray from their original mission of discovering and manufacturing useful drugs and instead become vast marketing machines with unprecedented control over their own fortunes. She saw them gain nearly limitless influence over medical research, education, and how doctors do their jobs. She sympathized as the American public, particularly the elderly, struggled and increasingly failed to meet spiraling prescription drug prices. Now, in this bold, hard-hitting new book, Dr. Angell exposes the shocking truth of what the pharmaceutical industry has become–and argues for essential, long-overdue change. Currently Americans spend a staggering $200 billion each year on prescription drugs. As Dr. Angell powerfully demonstrates, claims that high drug prices are necessary to fund research and development are unfounded: The truth is that drug companies funnel the bulk of their resources into the marketing of products of dubious benefit. Meanwhile, as profits soar, the companies brazenly use their wealth and power to push their agenda through Congress, the FDA, and academic medical centers. Zeroing in on hugely successful drugs like AZT (the first drug to treat HIV/AIDS), Taxol (the best-selling cancer drug in history), and the blockbuster allergy drug Claritin, Dr. Angell demonstrates exactly how new products are brought to market. Drug companies, she shows, routinely rely on publicly funded institutions for their basic research; they rig clinical trials to make their products look better than they are; and they use their legions of lawyers to stretch out government-granted exclusive marketing rights for years. They also flood the market with copycat drugs that cost a lot more than the drugs they mimic but are no more effective. The American pharmaceutical industry needs to be saved, mainly from itself, and Dr. Angell proposes a program of vital reforms, which includes restoring impartiality to clinical research and severing the ties between drug companies and medical education. Written with fierce passion and substantiated with in-depth research, The Truth About the Drug Companies is a searing indictment of an industry that has spun out of control.
